§ 864.5680. Automated heparin analyzer.
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/us/cfr/t21/s§ 864.5680·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
(b)Classification. Class II (special controls). [45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, 1993]